Question 1

What types of medical devices does Manukamed Limited Partnership manufacture?

Accepted Answer

Manukamed Limited Partnership specializes in wound care dressings, including exudate-absorbent dressings (both antimicrobial and non-antimicrobial), cavity-wound management dressings, adhesive bandages, and nonadherent dressings. Their portfolio also includes sterile honey-based ointments for topical wound treatment, such as First Honey Manuka Dressings and First Honey Sterile Honey Ointment. These products are designed to manage wound exudate, promote healing, and provide antimicrobial protection where applicable.

Question 2

Where is Manukamed Limited Partnership based?

Accepted Answer

Manukamed Limited Partnership is based in the United States. The company operates as a domestic manufacturer, focusing on developing and producing wound care solutions tailored for clinical and home use.

Question 3

Which regulatory registries or databases list Manukamed Limited Partnership’s devices?

Accepted Answer

Manukamed Limited Partnership’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, allowing them to identify and verify the products in clinical settings.

Question 4

How are Manukamed Limited Partnership’s devices classified under FDA regulations?

Accepted Answer

Manukamed Limited Partnership’s devices fall under FDA’s Class I and Unclassified (U) categories. Class I devices are generally considered low-risk and typically require less regulatory oversight, while Unclassified devices may have unique characteristics that warrant specific evaluation. The classification helps determine the regulatory pathway for each product.

Device	Model / Reference	Registries	Class	Status
First Honey Manuka Dressings	FH0161	FDA UDI	U	Active
MANUKAhd SuperLite Rolls	MM0074	FDA UDI	U	Active
MANUKAtex 10 x 12.5 cm	MM0010	FDA UDI	U	Active
MEDSAF 5 x 5cm	MM0120	FDA UDI	Class I	Active
MANUKAhd 10 x 12.5 cm	MM0017	FDA UDI	U	Active
First Honey Sterile Honey Ointment (1.0 Oz)	FH0049D	FDA UDI	U	Active
First Honey Manuka Bandages	MM0160	FDA UDI	U	Active
First Honey Sterile Honey Ointment (0.5 Oz)	FH0052	FDA UDI	U	Active
MANUKAhd Lite 10 x 12.5 cm	MM0031	FDA UDI	U	Active
MANUKAhd Lite 5 x 5 cm	MM0013	FDA UDI	U	Active
MANUKAhd Super Lite 10 x 12.5 cm	MM0071	FDA UDI	U	Active
MANUKAhd Super Lite 5 x 5 cm	MM0070	FDA UDI	U	Active
ManukaPli 44ge	MM0051	FDA UDI	U	Active
First Honey Sterile Honey Ointment (1.0 Oz)	FH0049	FDA UDI	U	Active
MANUKAtex 10 x 122 cm	MM0012	FDA UDI	U	Active
ManukaPli Sterile Honey Ointment (15g)	MM0049	FDA UDI	U	Active
MEDSAF Roll 10 x 99cm	MM0122	FDA UDI	Class I	Active
First Honey Manuka Bandages	FH0160	FDA UDI	U	Active
ManukaMed Adhesive Dressings	MM0161	FDA UDI	U	Active
MANUKAhd Lite 5 x 5 cm	MM0030	FDA UDI	U	Active
MEDSAF 10 x 12.5cm	MM0121	FDA UDI	Class I	Active
MANUKAhd Lite Border 10 x 10 cm	MM0032	FDA UDI	U	Unknown

MANUKAMED LIMITED PARTNERSHIP

What MANUKAMED LIMITED PARTNERSHIP makes

Frequently asked questions

Information

Catalogue (22)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities

FDA Establishments (1)